Statutory Instruments
2008 No. 2297
Medicines
F1 The Veterinary Medicines Regulations 2008
Made
26th August 2008
Laid before Parliament
1st September 2008
Coming into force
1st October 2008
The Secretary of State is a Minister designated( 1 ) for the purposes of making Regulations under section 2(2) of the European Communities Act 1972( 2 ) in relation to measures in the veterinary and phytosanitary fields for the protection of public health.
The Secretary of State has carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety( 3 ).
In accordance with section 56(1) of the Finance Act 1973( 4 ), the Treasury consent to the making of these Regulations.
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.
F1 PART 1 Introduction
Title and commencement
F1 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Definition of “veterinary medicinal product”, interpretation and scope
F1 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Products to which these Regulations do not apply
F1 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1 PART 2 Authorised veterinary medicinal products
Placing a veterinary medicinal product on the market
F1 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacture of veterinary medicinal products
F1 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The finished product
F1 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Classification, supply and possession of the product
F1 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration of the product
F1 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Importation of authorised veterinary medicinal products
F1 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising the product
F1 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising of prescription products and products containing psychotropic drugs or narcotics
F1 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Defence of publication in the course of business
F1 12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wholesale dealing
F1 13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Feedingstuffs
F1 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exemptions
F1 15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees
F1 16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1 PART 3 Records
Food-producing animals: proof of purchase of veterinary medicinal products
F1 17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of administration by a veterinary surgeon
F1 18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of acquisition and administration
F1 19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: retention of records
F1 20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a manufacturing authorisation
F1 21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a wholesale dealer’s authorisation
F1 22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of the receipt or supply of prescription products
F1 23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of products administered to a food-producing animal under the cascade
F1 24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F1 PART 4 Unauthorised veterinary medicinal products
Importation of an unauthorised veterinary medicinal product
F1 25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession of an unauthorised veterinary medicinal product
F1 26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of an unauthorised veterinary medicinal product
F1 27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Miscellaneous provisions, enforcement and offences
The Veterinary Products Committee
F1 28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Veterinary Products Committee appeals procedure
F1 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to an appointed person
F1 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exports
F1 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits
F1 32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment of inspectors
F1 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of entry
F1 34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of an inspector
F1 35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of pharmacies
F1 36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Obstruction
F1 37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Improvement notices
F1 38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals against improvement notices
F1 39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of a court on appeal
F1 40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Seizure notices
F1 41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Publication
F1 42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Penalties
F1 43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Northern Ireland
F1 44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocations and consequential amendment
F1 45. — (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2) In section 1 of the Medicines Act 1971( 5 ) (fees), in subsection (3), for “as amended by the Transfer of Functions (Wales) Order 1969 have the same meanings in this section as in that Act as so amended” substitute “(as amended) have the same meanings in this section as in that Act (as amended)”.
Jonathan Shaw
Parliamentary Under Secretary of State
Department for Environment, Food and Rural Affairs
Dave Watts
Alan Campbell
Two of the Lords Commissioners of Her Majesty’s Treasury
Regulation 4(3)
F1 SCHEDULE 1 Marketing authorisations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 5(2)
F1 SCHEDULE 2 The manufacture of veterinary medicinal products
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 7
F1 SCHEDULE 3 Classification and supply, wholesale dealers and sheep dip
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 8
F1 SCHEDULE 4 Administration of a veterinary medicinal product outside the terms of a marketing authorisation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 14
F1 SCHEDULE 5 Medicated feedingstuffs and specified feed additives
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 15(4)
F1 SCHEDULE 6 Exemptions for small pet animals
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 16
F1 SCHEDULE 7 Fees
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
S.I. 1999/2027 .
OJ No. L31, 1.2.2002, p. 1.
1971 c.69 , as amended by section 21 of the Health and Medicines Act 1988 (c. 49) and S.I. 1994/3144 , 2004/1031 , 2005/2750 and 2006/2407 .